Systems, apparatuses, and methods for providing non-transcranial electrotherapy

ABSTRACT

Systems, apparatuses, and methods for providing non-transcranial electrical stimuli to a biological subject may employ a support structure, at least one waveform generator, and at least a first electrode and a second electrode. The system can be sized and dimensioned to be worn on a head of the biological subject and operable to deliver non-transcranial electrical stimuli to at least one of the temporomandibular joints of the biological subject.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application claims the benefit under 35 U.S.C. §119(e) of U.S.Provisional Patent Application No. 61/074,530, filed Jun. 20, 2008;which is incorporated herein by reference in its entirety.

BACKGROUND

1. Technical Field

This disclosure generally relates to the field of electrotherapy and,more particularly, to system, devices, and methods for providingnon-transcranial electrotherapy to a biological subject.

2. Description of the Related Art

The term temporomandibular joint (TMJ) disorder, sometimes referred toas temporomandibular disorder, TMJ syndrome, or myofacial paindysfunction syndrome, encompasses a whole spectrum of conditions anddiseases associated with pain and/or dysfunction in the jaw joint andthe muscles that control jaw movement. These conditions and diseasesinclude injured or damaged tissues affecting the function of the TMJ,discomfort or pain in the muscles that control jaw function,displacement of a TMJ disc, a dislocated jaw, an injury to the condyle,derangements of the articulating elements in the TMJ, degenerative orinflammatory joint disorders, progressive degenerative and very painfulbreakdown of TMJ cartilage, tenderness and pain of the TMJ, and pivotingof the jaw. It has been estimated that about 8 to 15 percent of womenand about 3 to 10 percent of men experience pain associated with TMJdisorder. There are no known cures for TMJ disorder.

Conventional conservative treatments for TMJ disorder include eatingsoft foods, applying ice packs, avoiding extreme jaw movements, learningtechniques for relaxing and reducing stress, as well as short-term useof over-the-counter pain medicines, nonsteroidal anti-inflammatorydrugs, muscle relaxants, or anti-depressants. Conventional conservativetreatments often provide only temporary pain relief.

Conventional irreversible TMJ disorder treatments include surgery,orthodontics to change the bite, crown and bridge work to balance thebite, grinding down teeth to bring the bite into balance, andrepositioning splints (e.g., orthotics), which permanently alter thebite. Surgical treatments, such as the replacement of jaw joints withartificial implants, are often irreversible and in some cases may causesevere pain and permanent jaw damage. For example, some artificialimplants may fail to function properly or may break apart in the jawover time.

Bone and other tissues such as cartilage respond to electrical signalsin a physiologically useful manner. For example, electric andelectromagnetic fields regulate extra-cellular matrix synthesis andstimulate repair of fractures and nonunions. Other less well-knownoutcomes attributed to bioelectrical stimulation are positive bonedensity changes (Tabrah, 1990), and prevention of osteoporosis (Chang,2003). A recent report offered adjunctive evidence that stimulation withpulsed electromagnetic field (PEMF) significantly accelerates boneformed during distraction osteogenesis (Fredericks, 2003).

A disadvantage of most electrotherapeutic devices now available,however, is that they often rely on direct implantation of electrodes(or entire electronic packages), or they rely on inductive couplingthrough the skin using coils which generate time-varying magneticfields, thereby inducing weak eddy currents within body tissues whichinefficiently provide the signal to tissues. Consequently, in additionto bulky coils these systems require relatively large signal generatorsand battery packs. The need for surgery and biocompatible materials inthe one case, and excessive circuit complexity and input power in theother, has kept the price of most such apparatus relatively high, andhas also restricted the application of such devices to highly trainedpersonnel. Further, it is noted that TENS (Class II) medical devices arecontra-indicated for use on the head.

Accordingly, there remains a need for a versatile, cost-effective systemthat can be used to provide bioelectric stimulation in a wide range ofapplications, including healing acceleration and pain relief. There isalso a need in the art for a bioelectric stimulation system that ispower efficient, capable of being powered by safe, low-voltagebatteries, and can reduce the likelihood of a shock hazard.

The present disclosure is directed to overcoming one or more of theshortcomings set forth above, and/or providing further relatedadvantages.

BRIEF SUMMARY

In one aspect, the present disclosure is directed to an apparatus toprovide a non-transcranial electrical stimulus to a biological subject.The term “non-transcranial electrical stimulation” generally refers tothe non-evasive induction, delivery, and/or generation of an electricalcurrent without substantially inducing, delivering, and/or generating,an electrical current across a region of the brain. Conversely, the term“transcranial electrical stimulation” or “cerebral electricalstimulation” generally refers to the non-evasive induction, delivery,and/or generation, of an electrical current across a region of thebrain. Transcranial electrical stimulation has been used to, forexample, directly stimulate the brain with low-level direct current, orto activate the motor cortex thorough the skull.

In some embodiments, the apparatus includes a support structure, atleast one waveform generator, and at least a first electrode and asecond electrode. The support structure can be sized and dimensioned tobe worn on a head of the biological subject.

The at least one waveform generator can be carried by the supportstructure and configured to generate an electrical waveform. In someembodiments, the at least one waveform generator is configured togenerate one or more waveforms selected from continuous waveforms, pulsewaveforms, single-sine waveforms, multi-sine waveforms, frequency-sweptsine waveforms, step waveforms, square waveforms, triangular waveforms,saw-tooth waveforms, arbitrary waveforms, generated waveforms, chirpwaveforms, non-sinusoidal waveforms, ramp waveforms, regular orirregular waveforms, or combinations thereof, including single andmulti-frequency formed waves.

The at least first and second electrodes are carried by the supportstructure and are electrically coupled to the waveform generator. Theimprovement includes the spacing of the first and second electrodes suchthat the first electrode is sufficiently spaced apart from the secondelectrode so as to generate a first non-transcranial therapeuticelectric stimulus operable to flow through a region within thebiological subject in response to a generated electrical waveform fromthe at least one waveform generator.

In some embodiments, at least one of the first electrode or secondelectrode may include a first electrically conductive contactingsurface. The first electrically conductive contacting surface is adaptedto contact a surface of the biological subject and to provide the firstnon-transcranial therapeutic electric stimulus to the biologicalsubject.

In another aspect, the present disclosure is directed to a method forproviding a non-transcranial electrical stimulus to a biologicalsubject. The method employs a wearable electrotherapy system adapted tobe worn on a head of the biological subject, the wearable electrotherapysystem is configured to retain at least a first plurality of electrodesproximate to at least one temporomandibular joint of the biologicalsubject, when the wearable electrotherapy system is worn. Theimprovement includes spacing the first plurality of electrodessufficiently spaced apart so as to generate an electric field within thebiological subject in response to a first electric current, withoutgenerating an appreciable electric field across a region of the brain ofthe biological subject.

In some embodiments, the method may further include applying asufficient amount of an electrical current to the first plurality ofelectrodes so as to generate a non-transcranial electric field in aregion that encompasses at least one temporomandibular joint of thebiological subject.

In yet another aspect, the present disclosure is directed to a methodfor treating a condition associated with a temporomandibular jointdisorder. The improvement includes delivering a first non-transcranialelectric current from a first electrode assembly located proximate to afirst temporomandibular joint of a biological subject. The method mayfurther include delivering a second non-transcranial electric currentfrom a second electrode assembly located proximate to a secondtemporomandibular joint of the biological subject.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

In the drawings, identical reference numbers identify similar elementsor acts. The sizes and relative positions of elements in the drawingsare not necessarily drawn to scale. For example, the shapes of variouselements and angles are not drawn to scale, and some of these elementsare arbitrarily enlarged and positioned to improve drawing legibility.Further, the particular shapes of the elements, as drawn, are notintended to convey any information regarding the actual shape of theparticular elements, and have been solely selected for ease ofrecognition in the drawings.

FIG. 1 is a side view of a mandible, temporal bone, andtemporomandibular joint of biological subject according to oneillustrated embodiment.

FIG. 2 is an exploded cross-sectional view of a portion of thetemporomandibular joint of FIG. 1 according to one illustratedembodiment.

FIG. 3 is a front view of user wearing an apparatus, in the form of awearable electrotherapy system adapted to be worn on a head of a user,for providing a non-transcranial electrical stimulus to the user,according to one illustrated embodiment.

FIG. 4 is a side view of user wearing an apparatus, in the form of aheadset including electrodes configured to surround an ear, forproviding a non-transcranial electrical stimulus to the user accordingto another illustrated embodiment.

FIG. 5 is a schematic view of a waveform used in stimulating bonefracture healing according to one illustrated embodiment.

FIG. 6 is a schematic view of an effective electrical signal waveform inpulse mode based on an inductive coil waveform, which is adapted forskin application for promoting mineralization of bone, according to oneillustrated embodiment.

FIG. 7 provides an illustration showing an effective electrical stimuluswaveform in continuous mode for promoting mineralization of bone,according to one illustrated embodiment.

FIG. 8 is a schematic view of an effective electrical stimulus waveformin pulse mode for promoting proliferation of bone cells, according toone illustrated embodiment.

FIG. 9 is a schematic view of an effective electrical stimulus waveformin continuous mode for promoting proliferation of bone cells, accordingto one illustrated embodiment.

FIG. 10 is a schematic diagram of a system for providing anon-transcranial electrical stimulus to a biological subject, accordingto one illustrated embodiment.

FIG. 11 is a side view of a user wearing an apparatus, in the form of aheadset including electrodes configured to surround an ear, forproviding a non-transcranial electrical stimulus to the user, accordingto another illustrated embodiment.

FIG. 12 is side view of an electric field distribution in a regionencompassing a temporomandibular joint of the biological subject,according to one illustrated embodiment.

FIG. 13 is a side view of a user wearing an apparatus, in the form of aheadset including electrodes configured to surround an ear, forproviding a non-transcranial electrical stimulus to the user, accordingto another illustrated embodiment.

FIG. 14 is side view of an electric field distribution in a regionencompassing a temporomandibular joint of a biological subject,according to another illustrated embodiment.

FIG. 15 is a side view depiction of acupuncture points associated withthe left side of the head of a biological subject, according to oneillustrated embodiment.

FIG. 16 is a flow diagram of a method for treating a conditionassociated with a temporomandibular joint disorder, according to oneillustrated embodiment.

FIG. 17 is a flow diagram of a method for providing a non-transcranialelectrical stimulus to a biological subject, according to oneillustrated embodiment.

DETAILED DESCRIPTION

In the following description, certain specific details are included toprovide a thorough understanding of various disclosed embodiments. Oneskilled in the relevant art, however, will recognize that embodimentsmay be practiced without one or more of these specific details, or withother methods, components, materials, etc. In other instances,well-known structures associated with electrically powered devicesincluding but not limited to voltage and/or current regulators have notbeen shown or described in detail to avoid unnecessarily obscuringdescriptions of the embodiments.

Unless the context requires otherwise, throughout the specification andclaims which follow, the word “comprise” and variations thereof, suchas, “comprises” and “comprising” are to be construed in an open,inclusive sense, that is as “including, but not limited to.”

Reference throughout this specification to “one embodiment,” or “anembodiment,” or “in another embodiment,” or “in some embodiments,” meansthat a particular referent feature, structure, or characteristicdescribed in connection with the embodiment is included in at least oneembodiment. Thus, the appearance of the phrases “in one embodiment,” or“in an embodiment,” or “in another embodiment,” or “in someembodiments,” in various places throughout this specification are notnecessarily all referring to the same embodiment. Furthermore, theparticular features, structures, or characteristics may be combined inany suitable manner in one or more embodiments.

It should be noted that, as used in this specification and the appendedclaims, the singular forms “a,” “an,” and “the” include plural referentsunless the content clearly dictates otherwise. Thus, for example,reference to an apparatus to provide a non-transcranial electricalstimulus to a biological subject including a “support structure”includes a single support structure, or two or more support structures.It should also be noted that the term “or” is generally employed in itssense including “and/or” unless the content clearly dictates otherwise.

As shown in FIGS. 1 and 2, the temporomandibular joint 10 is theball-and-socket joint located on each side of the head where the lowerjawbone (mandible) 12 joins the temporal bone 14 of the skull. Thenormal human skull has two temporomandibular joints, one on the rightand one on the left.

The lower jawbone 12 has rounded ends (condyles) 18 that glide in andout of the joint socket 20 during talking, chewing, or yawning. As showin FIG. 2, the surfaces of the condyle 18 and the socket of the temporalbone 14 are covered with cartilage 22 and separated by a small articulardisk 24 (also known as the meniscus), which absorbs shock and keeps themovement smooth. The articular disk 24 divides the joint cavity into twosmall spaces and provides the gliding surface for the condyle 18,resulting in smooth joint movement. Muscles enable opening and closingof the mouth, and stabilize the temporomandibular joint 10.

As previously noted, the term temporomandibular joint disorderencompasses a whole spectrum of conditions and diseases associated withpain and/or dysfunction in the jaw joint and the muscles that controljaw movement. In some embodiments, the problem of reliving pain orstimulating healing of a condition associated with temporomandibularjoint disorder is solved by applying an electric stimulus (e.g., lowenergy waveforms (such as those provided by MedRelief®), transcutaneouselectrical nerve stimulation (TENS), interferential current therapy(IFC) stimulus, and the like, or combinations thereof) to a regionincluding a temporomandibular joint 10. In some embodiments, the problemof relieving pain or stimulating healing of a condition associated withtemporomandibular joint disorder is solved by the delivery of abioelectrical stimulus optimized to correspond to natural body signalsresulting in accelerated and more permanent healing. In someembodiments, one or more of the disclosed electrical stimuli describedherein uniquely conforms to natural signals and consequently tissuessubjected to electrostimulation undergo less physiological stress whencompared to electrostimulation from previous devices.

FIG. 3 shows an exemplary apparatus 50 for providing a non-transcranialelectrical stimulus to a biological subject. The apparatus 50 includes asupport structure 52, at least one waveform generator 54, and at least afirst electrode 56 and a second electrode 58. In some embodiments, theapparatus 50 may further include at least a third electrode 60 and afourth electrode 62.

The support structure 52 can be sized and dimensioned to be worn on ahead of a user. Any suitable structure may be used as the supportstructure 52. Examples of the support structure 52 include headsets,headbands, fastening clips (sized and dimensioned to be worn on or overan ear), ear-buds, ear-cups, and the like. In some embodiments, thesupport structure 52 is constructed and arranged to transfer a portionof a force applied by the support structure 52 to a temporal region 66of the user so as to maintain the first and second electrodes 56, 58relatively stationary with respect to a region proximate an ear and/or atemporomandibular joint 10 of a user. The support structure 52 caninclude a fastening clip configured to surround an ear of the biologicalsubject and maintain the first and second electrodes 56, 58 proximate anear and/or a temporomandibular joint 10 of a user. In some embodiments,the support structure 52 is constructed and arranged to quickly andconveniently affix one or more of the electrodes around an ear and/orproximate the temporomandibular joint 10 of a user. The supportstructure 52 may include one or more fitting assemblies 68 for adjustingthe position of the one or more electrodes carried by the supportstructure 52. In some embodiments, the fitting assemblies 68 permitsymmetrically or asymmetrically adjustment of the length of the supportstructure 52.

In some embodiments, the apparatus 50 may include one or moreover-the-ear structures 70, such as, for examples headphones, earphones,noise cancelling headphones, earcups, sound-attenuating earcups,sound-blocking cups, cup-shaped shells, and the like coupled to thesupport structure 52. The over-the-ear structures 70 may furtherinclude, for example, a component that covers a portion or the entireear, or a component that simply surrounds an ear of the user. In someembodiments, one or more of the electrodes may be incorporate orconnected to the over-the-ear structures 70. In some embodiments, partor most of the skin contacting surfaces of the over-the-ear structures70 may be electrically conductive and serve as electrodes. In someembodiments, some or all of the electrodes, stimulation circuitry, andpower is contained within the over-the-ear structures 70.

In some embodiments, the apparatus 50 may include one or more earphoneunits 72, with each earphone unit 72 having a transducer 76 operable tooutput an audio signal. In some embodiments, the apparatus 50 mayinclude an ambient noise cancelling apparatus 74 coupled to a noisecancelling-circuit 76. In some embodiments, the ambient noise cancellingapparatus 74 is operable to provide a noise cancelling signal to thetransducer 76 to provide active acoustic noise cancellation when theapparatus 50 is worn by the biological subject.

In some embodiments, electrically isolated left and right channels areprovided. Alternatively, a wireless audio feature might be providedwith, for example, an FM tuner built in and powered by the same batteryas the stimulator. An inexpensive FM modulator could then act as bridgebetween the headphones and a non-broadcast source.

In some other embodiments, the first and the second electrodes 56, 58are sufficiently spaced apart so as to generate a localized electricfield in tissue associated with a temporomandibular joint 10 of thebiological subject such that at least 10% of the localized electricfield passes through the temporomandibular joint 10. In someembodiments, the first and the second electrodes 56, 58 are spaced apartby the presence of a suitable electrically insulation material.

In some other embodiments, the first electrode 56 is spatiallypositioned in the range from about twice the length of atemporomandibular joint 10 to about four times the length oftemporomandibular joint 10 away from the second electrode 58. In someembodiments, the apparatus 50 may further comprise a third electrode 60and a fourth electrode 62 carried by the support structure andelectrically coupled to the waveform generator, the third electrode 60being sufficiently spaced apart from the fourth electrode 62 so as togenerate a second non-transcranial therapeutic electric stimulusoperable to flow through a region within the biological subject inresponse to a generated electrical waveform from the at least onewaveform generator 54.

In some embodiments, the apparatus 50 includes a first coupling memberbetween the support structure and the first and the second electrodes56, 58, and a second coupling member between the support structure 52and the third and the fourth electrodes 60, 62, the first and secondcoupling members configured to releasably hold the first and the secondelectrodes 56, 58, and the third and the fourth electrodes 60, 62,respectively. In some embodiments, the apparatus 50 is operable to allowoperation of the first, the second, the third, and the fourth electrodes56, 58, 60, 62 individually or jointly. In some embodiments, theapparatus 50 is operable to allow concurrent or sequential operation ofthe first and the second electrodes 56, 58, and the third and a fourthelectrodes 60, 62.

The at least one waveform generator 54 is carried by the supportstructure 52 and configured to generate an electrical waveform. In someembodiments, the waveform generator 54 may comprise at least one of aprocessor, a wave-shaping circuit, a digital signal processor basedwaveform generator, and the like. The waveform generator 54 may becoupled (for example, electrically, wirelessly, and/or inductivelycoupled or connected) to a one or more of the electrodes and operable togenerated an electrical waveform when activated.

In some embodiments, the least one waveform generator 54 is configuredto generate one or more waveforms selected from single-sine waveforms,multi-sine waveforms, frequency-swept sine waveforms, step waveforms,pulse waveforms, square waveforms, triangular waveforms, saw-toothwaveforms, arbitrary waveforms, generated waveforms, chirp waveforms,non-sinusoidal waveforms, ramp waveforms, or combinations thereof,including single and multi-frequency formed waves. In some embodiments,the least one waveform generator 54 is operable to generate low energywaveforms such as those provided by MedRelief®), transcutaneouselectrical nerve stimulation (TENS), interferential current therapy(IFC) stimulus, and the like, or combinations thereof.

In some embodiments, the generated waveform comprises intermittentbursts of quasi-rectangular waves (waves of generally rectangular shapebut typically somewhat distorted), based on a plurality of relativelylong primary timing intervals T1, T2 and so forth, forming in successiona primary repeating cycle; a plurality of shorter secondary timingintervals t1, t2 and so forth, into which at least one of said primaryintervals is divided, and forming in succession a secondary repeatingcycle which continues throughout the length of that primary interval,while at least one other of said primary intervals is not so divided;and a plurality of constant voltage or current levels L1, L2 and soforth, one of which is selected during each primary timing interval or,if that interval is divided, during each secondary timing intervalwithin it. The series of constant current or voltage levels which areselected during successive timing intervals comprises the waveform. Theaverage magnitude of these levels selected during a given primaryinterval determines the signal amplitude within that interval, and thesignal amplitudes within all primary intervals, taken in succession,comprise the envelope of the waveform.

In some embodiments, the waveforms generated by the waveform generator54 can be used to provide electrical stimuli and waveforms that enablespecific actions on biological tissues. Osteochondral tissues are shownherein to respond differently to markedly different frequencies andwaveforms.

In some embodiments, the waveforms generated by the waveform generator54 comprises alternating rectangular or quasirectangular pulses havingopposite polarities and unequal lengths, thereby forming rectangular,asymmetric pulse trains. Pulses of specific lengths have been theorizedto activate specific cell biochemical mechanisms, especially the bindingof calcium or other small, mobile, charged species to receptors on thecell membrane, or their (usually slower) unbinding. The portions of sucha train having opposite polarities may balance to yield substantially anet zero charge, and the train may be either continuous or divided intopulse bursts separated by intervals of substantially zero signal.Stimuli administered in pulse-burst mode have similar actions to thoseadministered as continuous trains, but their actions may differ indetail due to the ability (theoretically) of charged species to unbindfrom receptors during the zero-signal periods, and requiredadministration schedules may also differ.

In some embodiments, a PEMF (pulsed electromagnetic field) isadministered via electromagnetic coils. In some embodiments a PEF(pulsed electric field) is administered via electrochemical means (i.e.,skin-attached capacitively coupled electrodes). Both PEMF and PEF mayemploy a repetition of pulse train, and/or individual pulses. In someembodiments, the burst width (duration of the signal) may vary; however,the underlying signal itself remains the same for both PEMF and PEF. Incertain alternative embodiments, the pulse train may contain an addedsignal for no net charge.

FIG. 5 shows a schematic view of a base waveform 220 effective forstimulating bone and cartilage tissue, where a line 222 represents thewaveform in continuous mode, and a line 224 represents the same waveformon a longer time scale in pulse-burst mode, levels 226 and 228 representtwo different characteristic values of voltage or current, and intervals230, 232, 234, and 236 represent the timing between specifictransitions. Levels 226 and 228 are usually selected so that, whenaveraged over a full cycle of the waveform, there is no netdirect-current (DC) component although levels 226 and 228 may beselected to result in a net positive or net negative DC component ifdesired. In real-world applications, waveform such as 220 is typicallymodified in that all voltages or currents decay exponentially towardsome intermediate level between levels 226 and 228, with a decay timeconstant preferably longer than interval 234. The result is representedby a line 238. The waveforms described herein generally have two signalcomponents: a longer component shown as interval 230 and a shortercomponent shown as interval 232 relative to each other.

Variation in the short and long signal component lengths confersspecific effects of a stimulated tissue. In some embodiments, the pulselengths of interest may be defined as follows, in order of increasinglength. Length α: between 5 and 75 μsec in duration, in some embodimentsbetween 10 and 50 μsec in duration, in some embodiments between 20 and35 μsec in duration, and in some embodiments between about 28 μsec induration. Length β between 20 and 100 μsec in duration, preferablybetween 40 and 80 μsec in duration, in some embodiments between 50 and70 μsec in duration, and in some embodiments about 60 μsec in duration.Length γ between 100 and 1000 μsec in duration, in some embodimentsbetween 150 and 800 μsec in duration, in some embodiments between 180and 500 μsec in duration, and in some embodiments about 200 μsec induration. Length δ in excess of 1 millisecond in duration, in someembodiments between 5 and 100 msec in duration, in some embodimentsbetween 10 and 20 msec in duration, and in some embodiments about 13msec in duration.

In some embodiments, the electrical signal has a shorter component oflength α and a longer component of length β thus having, with the mostpreferable pulse lengths of each type (28 μsec and 60 μsecrespectively), a frequency of about 11.4 KHz. Signals comprised ofpulses alternately of length α and length β are referred to herein as“type A” signals and their waveforms as “type A” waveforms. An example a“type-A signal administered as a continuous pulse train is shown in FIG.6. These signals may be useful for promoting the proliferation of atissue sample or culture for a variety of biological or therapeuticapplications.

In pulse-burst mode, “type A” waveforms would be turned on in bursts ofabout 0.5 to 500 msec, in some embodiments about 50 msec, with burstsrepeated at 0.1-10 Hz or preferably about 1 Hz. An example of this typeof waveform is shown in FIG. 7.

In some embodiments, the electrical signal has a shorter component oflength α but a longer component of length γ: thus having, in someembodiments, pulse lengths of each type (28 μsec and 200 μsecrespectively), a frequency of about 4.4 KHz. Signals comprised of pulsesalternately of length α and length γ are referred to herein as “type B”signals and their waveforms as “type B” waveforms. Such waveforms werepreviously described in U.S. patent application Ser. No. 10/875,801(publication No. 2004/0267333). An example of a “type-B” signaladministered as a continuous pulse train is shown in FIG. 8. Thesesignals are useful in pain relief and in promoting bone healing, andalso stimulate the development of cancellous-bone-like structures inosteoblast cultures in vitro, with applications to the field of surgicalbone repair and grafting materials.

In pulse-burst mode, “type B” waveforms are turned on in bursts of about1 to 50 msec, in some embodiments about 5 msec, with bursts repeated at5-100 Hz or in some embodiments about 15 Hz. An example of this type ofwaveform is shown in FIG. 9. This waveform is similar in shape andamplitude to effective currents delivered by typical inductive (coil)electromagnetic devices that are commonly used in non-union bonestimulation products e.g. EBI MEDICA, INC® (Parsippany, N.J.) andORTHOFIX, INC® (McKinney, Tex.).

In some embodiments, the electrical signal has a shorter component oflength β but a longer component of length γ: thus having, with the mostpreferable pulse lengths of each type (60 μsec and 200 μsecrespectively) a frequency of about 3.8 KHz. Signals comprised of pulsesalternately of length β and length γ are referred to herein as “type C”signals and their waveforms as “type C” waveforms. These signals areuseful in promoting bone regeneration, maturation, and calcification.

In pulse-burst mode, “type C” waveforms are turned on in bursts of about1 to 50 msec, in some embodiments about 5 msec, with bursts repeated at5-100 Hz or in some embodiments about 15 Hz, much the same as “type B.”This waveform is similar in shape and amplitude to effective currentsdelivered by other typical inductive (coil) electromagnetic devicescommonly used in non-union bone stimulation products, e.g. the ORTHOFIX,INC® (McKinney, Tex.) PhysioStim Lite®, which is designed to promotehealing of spinal fusions.

In some embodiments, the electrical signal has a shorter component oflength γ and a longer component of length δ: thus having, in someembodiments, pulse lengths of each type (200 μsec and 13 msecrespectively) a frequency of about 75 Hz. Signals comprised of pulsesalternately of length γ and length δ are referred to herein as “type D”signals and their waveforms as “type D” waveforms. These signals areuseful especially in promoting cartilage healing and bone calcification,and in treating or reversing osteoporosis and osteoarthritis. Whilebroadly similar to that delivered through electrodes by the BIONICAREMEDICAL TECHNOLOGIES INC® BIO-1000®, as shown in FIG. 3 of U.S. Pat. No.5,273,033, the “type D” signal differs substantially in wave shape (itis rectangular rather than exponential) and in the fact that it ispreferably charge-balanced.

In pulse-burst mode, “type D” waveforms are turned on in bursts of atleast 100 msec, in some embodiments about 1 second, with bursts repeatedat intervals of one second or more.

The signal intensity may also vary; indeed, more powerful signals oftengive no more benefit than weaker ones, and sometimes less. For a typicalsignal (such as the signal of FIG. 5), a peak effectiveness typicallyfalls somewhere between one and ten microamperes per square centimeter(μA/cm²), and a crossover point at about a hundred times this value.Beyond this point, the signal may slow healing or may itself causefurther injury.

Of particular relevance to the present methods are electrical signals orwaveforms that run in continuous mode instead of burst mode. (Forexample FIG. 6 or 8). Continuously run signals have effects similar tothose of pulse-burst signals, but may require different delivery regimesto achieve similar results.

In some embodiments, the applied average current densities of thedisclosed waveforms range from about 0.1 to about 1000 microamperes persquare centimeter. In some embodiments, the applied average currentdensities range from about 0.3 to about 300 microamperes per squarecentimeter. In some embodiments, the applied average current densitiesrange from about 1 and 100 microamperes per square centimeter, and insome embodiments about 10 microamperes per square centimeter, resultingin voltage gradients ranging between 0.01 and 1000, 0.03 and 300, 0.1and 100, and 1 and 10 microamperes per centimeter, respectively, intypical body tissues. The individual nearly-square wave signal isasynchronous with a long positive segment and a short negative segmentor vice versa. The positive and negative portions balance to yield azero net charge or optionally may be charge imbalanced with anequalizing pulse at the end of the pulse to provide zero net chargebalance over the waveform as a whole. These waveforms delivered by skinelectrodes use continuous rectangular or approximately rectangularrather than sinusoidal or strongly exponentially decaying waveforms.Other waveforms useful in conjunction of the disclosed methods aredisclosed in, for example, published U.S. patent application Ser. No.10/875,801 (publication No. 2004/0267333).

In some embodiment, one or more of the disclosed electrical stimuli maybe administered to cells, biological tissues, or individuals in need oftreatment for intermittent treatment intervals or continuouslythroughout the day. A treatment interval is defined herein as a timeinterval that a waveform is administered in pulse or continuous mode.Treatment intervals may be about 10 minutes to about 4 hours induration. In some embodiments, the treatment intervals may be from about30 minutes to about 2.5 hours in duration. In some embodiments, thetreatment intervals are about 1 hour in duration. Treatment intervalsmay occur between about 1 and 100 times per day. The duration andfrequency of treatment intervals may be adjusted for each case to obtainan effective amount of electrical stimulation to promote cellproliferation, cell differentiation, bone growth, development, painrelief, repair, or the like. The parameters are adjusted to determinethe most effective treatment parameters.

Signals do not necessarily require long hours of duration in thetreatment interval although 24 hour administration may be used ifdesired. Typically, 30 minutes (repeated several times a day) isrequired for biological effectiveness. In vitro cell proliferation maybe measured by standard means such as cell counts, increases in nucleicacid or protein synthesis. Upregulation or down regulation of matrixproteins (collagen types I, III, and IV) as well as growth factors andcytokines (such as TGF-B, VEGF, SLPI, FN, MMPs) may also be measured(mRNA and protein synthesis). In vivo effects may be determined by rateof healing of an injury or measuring bone mass density. Other diagnosticmethods for proliferation, differentiation, or mineralization of bonetissue may be employed.

In one embodiment, proliferation-promoting and differentiation-promotingsignals are used sequentially. This combination of waveforms is used toincrease the cell number and then promote differentiation of the cells.As an example, the sequential use of proliferation and differentiationsignals may be used to promote proliferation of osteoblasts and thendifferentiation of the osteoblasts into mineral producing osteocytesthat promote mineralization of bone or vice versa. For example, atreatment paradigm may be used where a proliferation-promoting A-typesignal is administered first to a cell population in vitro or ex vivofor hours, days or weeks and then the proliferation promoting signal isreplaced with a mineralization-promoting B-type signal for hours, daysor weeks until bone mineralization has been effected. The tissueproduced may then be transplanted for patient benefit. Both signals mayalso be applied simultaneously to promote both proliferation, anddifferentiation and mineralization simultaneously.

The electric signals may be delivered by skin electrodes, orelectrochemical connection. Skin electrodes are available commerciallyin sizes such as 11/2×12, 2×31/2, and 2×2 inches. These reusableelectrodes are advantageous because they do not contain latex and havenot shown significant skin irritation. The reusable electrodes can beused multiple times; also reducing costs to the patient. Such electrodesmay include those by Koalaty Products Inc (Tampa, Fla.) or by Vermed,Inc. (Bellows Falls, Vt.).

There are multiple advantages of using skin electrodes instead ofelectromagnetic coils. Firstly, skin electrodes are more efficient. Withelectrodes, only the signal which will actually be sent into the bodymust be generated. With a coil, because of poor electromagnetic couplingwith the tissues, the signal put in must be many, many times strongerthan that desired in the tissues. This makes the required generatingcircuitry for electrodes potentially much simpler than for coils, whilerequiring much less power to operate. Secondly, skin electrodes are moreuser friendly. Skin electrodes have at most a few percent of the weightand bulk of coils needed to deliver equivalent signal levels. Similarly,because of better coupling efficiency the signal generators to driveelectrodes can be made much smaller and lighter than those for coils.After a short time, a wearer hardly notices they are there. Thirdly,skin electrodes are more economical. Unlike coils, which cost hundredsto thousands of dollars each, electrodes are “throw-away” itemstypically costing less than a dollar. Also, because of greaterefficiency and simplicity, the signal generators and batteries to drivethem can be small and inexpensive to manufacture compared with those forcoils. Fourthly, skin electrodes permit simpler battery construction andlonger battery life facilitating the ease and patient compliance ofusing the device. Lastly, skin electrodes are more versatile thanelectromagnetic coils. Coils must be built to match the geometriccharacteristics of body parts to which they will be applied, and eachmust be large enough to surround or enclose the part to be treated. Withelectrodes, on the other hand, current distribution is determined byelectrode placement only and readily predictable throughout the volumebetween.

In some embodiments, the waveforms generated by the waveform generator54 can be useful in methods to promote the growth and repair of bonetissue in vivo. For example, stimulation with A-type waveforms (FIGS. 6and 7) promotes proliferation of cells. A-type waveforms may also resultin an increase in bone morphogenic proteins to promote differentiation.In some embodiments, an increase in BMP-2 and BMP-7 production iseffected using A-type or to a lesser degree, B-type electrical signals.This effect is highly valuable and provides a method for enhancing thegeneration of sufficient tissue for proper tissue healing in vivo, or tocreating tissue grafts. This signal is also valuable for providingsufficient cell mass for infiltration into a polymer scaffold for tissueengineering purposes. In another embodiment, as demonstrated by in vitrotesting, stimulation in vivo provides proliferation and differentiationof osteoblasts to increase the number of osteoblasts for mineralization.Such an increase in number of cells provides a method for filling ingaps or holes in developing or regenerating bone through electricalstimulation. Cells generated through proliferation induced by A-typewaveforms may be used immediately, or preserved using conventional cellpreservation methods until a future need arises.

Stimulation with B-type waveforms (FIGS. 8 and 9) promotes proliferationto a small degree, and has actions different than A-type waveforms.Actions promoted by B-type waveforms include, but are not limited tomineralization, extracellular protein production, and matrixorganization. The actions of B-type waveforms are also valuable andprovide methods to enhance the mineralization step and ossification ofnew bone tissue. In one embodiment, developing or regenerating bonetissue is stimulated with B-type waveforms to enhance the rate ofmineralization. It has been proposed that B-type waveforms may actthrough calcium/calmodulin pathways and also by stimulation of G-proteincoupled receptors or mechanoreceptors on bone cells. (Bowler, FrontBiosci, 1998, 3:d769-780; Baribault et al., Mol Cell Biol, 2006,26(2):709-717). As such, methods are also provided to modulate theactivity of calcium/calmodulin-mediated actions as well as G proteincoupled receptors and mechanoreceptors using electrical stimulation.Modulation of these cellular pathways and receptors are valuable topromote the growth and repair of bone tissue in vitro or in vivo.

Stimulation with C-type waveforms promotes bone regeneration,maturation, and calcification. These waveforms are also valuable andprovide methods to enhance the mineralization step and ossification ofnew bone tissue.

Stimulation using D-type waveforms promotes cartilage development andhealing and bone calcification, and is useful for treating or reversingosteoporosis and osteoarthritis. Applications of these waveforms includein vivo applications such as repairing damaged cartilage, increasingbone density in patients with osteoporosis.

Methods are also provided for combination or sequential use of thewaveforms described herein for the development of a treatment regime toeffect specific biological results on developing or regeneratingosteochondral tissue.

In some embodiments, fractures in patients with a bone disorder may betreated with signals to heal fractures and then strengthen the bone. Asa non-limiting example of this embodiment, an osteoporotic patient witha fracture may be treated by first stimulating with an A-type signal topromote proliferation and release of growth factors and then a B-typewaveform to promote an increase in bone density at the site of repair toincrease bone mass density and prevent refracture.

In another embodiment, combining two or more types of waveformsdescribed herein may be used to promote the sequential proliferation,differentiation, and mineralization of osteochondral tissues. As anon-limiting example of this embodiment, a culture of osteoblasts may begrown under the influence of a A-type signal in connection with or priorto connection with a polymeric matrix. After seeding the polymericmatrix, B-type signals are then administered to the cell-matrixconstruct to promote mineralization of a construct useful as a bonegraft.

In another embodiment, two or more signals may be administeredsimultaneously to promote concomitant proliferation, differentiation,and mineralization of osteochondral tissue in vivo or in vitro.Different signals may also be applied sequentially to osteochondraltissue in order to yield a greater effect than delivering either signalalone. The sequential process may be repeated as needed to produceadditional tissue (such as bone) by cycling through the two-step processenough times to obtain the desired biological effect. As a specificnon-limiting example, A-type signals may be applied first to producemore bone cells by proliferation and then B-type signals may be appliedto induce the larger number of bone cells to produce more bone tissue(matrix, mineral and organization) and then repeated if needed. Theamount of bone produced using repetition of a sequential stimulationprotocol would be greater than that produced by either signal alone orin combination.

In some embodiments, the least first electrode 56 and a second electrode58 are carried by the support structure 54 and coupled (for example,electrically, wirelessly, and/or inductively coupled or connected) tothe waveform generator 54, the first electrode 56 being sufficientlyspaced apart from the second electrode 58 so as to generate a firstnon-transcranial therapeutic electric stimulus operable to flow througha region within the biological subject in response to a generatedelectrical waveform from the at least one waveform generator 54, atleast one of the first electrode 56 or the second electrode 58 having afirst electrically conductive contacting surface 70. In someembodiments, the first electrically conductive contacting surface 70 isadapted to contact a surface of the biological subject and to providethe first non-transcranial therapeutic electric stimulus to thebiological subject. In some other embodiments, the first electricallyconductive contacting surface conforms to a biological surface proximateto a temporomandibular joint 10 of the biological subject. For example,in some embodiments, the first electrically conductive contactingsurface is adapted to conform to the outer contours of a biologicalsurface such as an ear, a skin region proximate and/or overlying atemporomandibular joint 10, and the like. In some embodiments, the firstelectrically conductive contacting surface is adapted to lie over and/orpress against one or more acupuncture points found on a biologicalsurface (e.g., an outer surface of an ear, regions proximate atemporomandibular joint, and the like).

In some other embodiments, at least part of the first electrode 56, thesecond electrode 58, or both comprises at least one electricallyconductive material selected from, silver plated textiles, textilesinterwoven with conductive materials, textiles interwoven with silverthreads, semiconductor materials, graphite fibers, carbon nanotubes,conductive plastics, conductive polymers, and the like.

Referring to FIGS. 3 and 4, in some embodiments, the apparatus 50 takesthe form of a wearable electrotherapy system 50 a adapted to be worn ona head of the biological subject and to provide non-transcranialtherapeutic electric stimulus. The wearable electrotherapy system 50 ais configured to retain at least a first plurality of electrodes 80proximate to at least one temporomandibular joint 10 of the biologicalsubject when the wearable electrotherapy system 50 a is worn. In someembodiments, the first plurality of electrodes 80 is sufficiently spacedapart so as to generate an electric field 82 within the biologicalsubject in response to a first electric current. In some embodiments,the wearable electrotherapy system 50 a includes electrodes 56 a, 58 bconfigured to surround an ear, for providing a non-transcranialelectrical stimulus to the user according to another illustratedembodiment. In some embodiments, the wearable electrotherapy system 50 aprovides the user convenient walk around freedom while receivingnon-transcranial therapeutic electric stimuli.

FIG. 10 shows a block diagram of a system 100 suitable to provide, forexample, a non-transcranial electrical stimulus to a biological subject.The system 100 may include one or more controllers 102 such as amicroprocessor 102 a, a central processing unit (CPU), a digital signalprocessor (DSP), an application-specific integrated circuit (ASIC), afield programmable gate array, or the like, or combinations thereof, andmay include discrete digital and/or analog circuit elements orelectronics.

The system 100 may further include one or more memories that storeinstructions and/or data, for example, random access memory (RAM) 104,read-only memory (ROM) 106, or the like, coupled to the controller 102by one or more instruction, data, and/or power buses 108. The system 100may further include a computer-readable media drive or memory slot 110,and one or more input/output components 112 such as, for example, agraphical user interface, a display, a keyboard, a keypad, a trackball,a joystick, a touch-screen, a mouse, a switch, a dial, or the like, orany other peripheral device. The system 100 may further include one ormore databases 114. The system 100 may further include at least onewaveform generator 116, and a first plurality of electrodes 118 aincluding at least a first electrode 120 and a second electrode 122. Insome embodiments, the system 50 may further include a second pluralityof electrodes 118 b including at least a third 124 and a fourthelectrode 126. In some other embodiments, the system 100 may furtherinclude at least one power source electrically coupleable to at leastone of the first 120 and the second electrodes 122.

In some embodiments, the problem of providing an electrical stimulus toa region associated with a temporomandibular joint 10 of a biologicalsubject without providing an appreciable electrical stimulus to a brainof a biological subject is solved by providing a wearable electrotherapysystem 100 adapted to be worn on a head of the biological subject. Thewearable electrotherapy system 100 is configured to retain at least afirst plurality of electrodes 118 a proximate to at least onetemporomandibular joint 10 of the biological subject when the wearableelectrotherapy system 100 is worn, and is operable to deliver anon-transcranial electrical stimulus.

In some embodiments, the waveform generator 116 comprises at least oneof a processor, a wave-shaping circuit, a digital signal processor basedwaveform generator, and the like, or combinations thereof. In someembodiments, the controller 102 is electrically coupled to the at leastone waveform generator 116 and operable to control the waveformgenerator 116. In some embodiments, a processor is electrically coupledto the at least one waveform generator 116 and operable to control thewaveform generator 116.

The computer-readable media drive or memory slot 110 may be configuredto accept computer-readable memory media. In some embodiments, a programfor causing the system 100 to execute any of the disclosed methods canbe stored on a computer-readable recording medium. Examples ofcomputer-readable memory media include CD-R, CD-ROM, DVD, data signalembodied in a carrier wave, flash memory (e.g., SD cards, compact flashcards, USB flash drives, memory sticks, multimedia cards, or the like),floppy disk, hard drive, magnetic tape, magnetooptic disk, MINIDISC,non-volatile memory card, EEPROM, optical disk, optical storage, RAM,ROM, system memory, web server, or the like.

In some embodiments, the system 100 is configured to deliver anon-transcranial electrical current that passes through tissueassociated with a temporomandibular joint 10 of the biological subjectin response to a generated electrical waveform from the at least onewaveform generator 116 when in use.

In some embodiments, the first electrode 120 is sufficiently spacedapart from the second electrode 122 so as to induce a non-transcranialelectrical current that passes through tissue associated with atemporomandibular joint 10 of the biological subject in response to agenerated electrical waveform from the at least one waveform generator116. In some other embodiments, the first electrode 120 is sufficientlyspaced apart from the second electrode 122 so as to generate anon-transcranial electrical current to a region of the biologicalsubject such that a major portion of the generated non-transcranialelectrical current is spaced apart from the brain of the biologicalsubject and passes through tissue associated a temporomandibular joint10. In some other embodiments, the first and the second electrodes 120,122 are spatially separated so as to deliver a pulsed electrical currentto a region of the biological subject including a temporomandibularjoint 10, when activated.

In some embodiments, the system 100 may further include one or moretransducer 132 operable to output an audio signal. In some embodiments,the system 100 may further include an ambient noise cancelling componentcoupled to a noise cancelling-circuit 134. In some embodiments, theambient noise cancelling component is operable to provide a noisecancelling signal to the transducer to provide active acoustic noisecancellation when the system 100 is worn by the biological subject.

Referring to FIGS. 11 through 15, in some embodiments, the first and thesecond electrodes 120, 122 are sufficiently spaced apart so as togenerate a substantially prolate spheroidical electric field 190encompassing a temporomandibular joint 10 of the biological subject inresponse to a generated electrical waveform from the at least onewaveform generator 116. In some other embodiments, the first and thesecond electrodes 120, 122 are positioned with respect to one another soas to generate a non-transcranial electrical field 190 occupying asubstantially prolate spheroidical region proximate to an ear of thebiological subject, when the first and the second electrodes 120, 122are activated. In some other embodiments, the first and the secondelectrodes 120, 122 are sufficiently spaced apart so as to transdermallydeliver a non-transcranial electrical current to a temporomandibularjoint 10 of the biological subject, when a potential is applied to thefirst and the second electrodes 120, 122.

In some embodiments, the non-transcranial electrical field 190 generatedbetween the first electrode 120 and the second electrode, includes thetemporomandibular joint 10 while having its endpoints located onAcupuncture points 192.

Referring to FIG. 15, in some embodiments, one or more over-the-earstructures 70 can be configured to lie over, press against, and/orelectrically stimulate one or more acupuncture points found on orproximate the ear and/or the temporomandibular joint 10 of thebiological subject. For example, the apparatus 50 can include one ormore over-the-ear structures 70 that are operable to electricallystimulate auricular acupuncture points of a user to relive a conditionassociated with a temporomandibular joint 10 disorder. For example, asshown in FIG. 13, in some embodiments, electrode 122 can be placed incontact with a region immediately in front of the ear and electrodewhile electrode 120 can be made to conform to the rear curve of the earand contact a region immediately behind the ear, such the each electrode120, 122 encompasses one or more acupuncture points 192 (e.g.,acupuncture points associated with the Gall bladder, Triple Warmerpoints (TW 18, 19, 20 and 21), the small intestine points (SI 18, and19,), and the like). According, when activated, the spaced apartelectrodes 120, 122 would generate an electric field 190 encompassing atemporomandibular joint 10, and one or more acupuncture points 192.

FIG. 16 shows an exemplary method 300 for treating a conditionassociated with a temporomandibular joint disorder.

At 302, the method 300 includes delivering a first non-transcranialelectric current from a first electrode assembly located proximate to afirst temporomandibular joint of a biological subject.

At 304, the method 300 includes delivering a second non-transcranialelectric current from a second electrode assembly located proximate to asecond temporomandibular joint of the biological subject.

In some embodiments, delivering the first non-transcranial electriccurrent includes providing a sufficient current to transdermally deliveran electrical current to the first temporomandibular joint of thebiological subject, and delivering the sufficient amount of the secondnon-transcranial electric current includes providing a sufficientcurrent to transdermally deliver an electrical current to the secondtemporomandibular joint of the biological subject. In some embodiments,delivering the first non-transcranial electric current and deliveringthe second non-transcranial electric current includes alternatingbetween delivering the first non-transcranial electric current anddelivering the second non-transcranial electric current for a selectedtime period.

In some embodiments, delivering the first non-transcranial electriccurrent includes supplying a sufficient amount of current to generate anon-transcranial electrical current field encompassing the firsttemporomandibular joint, and delivering the second non-transcranialelectric current includes supplying a sufficient amount of current togenerate a non-transcranial electrical current encompassing the secondtemporomandibular joint. In some embodiments, delivering the firstnon-transcranial electric current, and delivering the secondnon-transcranial electric current includes delivery of the firstnon-transcranial electric current for a first time period, followed bydelivery of the second non-transcranial electric current for a secondtime period.

FIG. 17 shows an exemplary method 350 for method for providing anon-transcranial electrical stimulus to a biological subject.

At 352, the method 350 includes providing a wearable electrotherapysystem adapted to be worn on a head of the biological subject. In someembodiments, the wearable electrotherapy system is configured to retainat least a first plurality of electrodes 118 a proximate to at least onetemporomandibular joint 10 of the biological subject when the wearableelectrotherapy system is worn, the first plurality of electrodes 118 abeing sufficiently spaced apart so as to generate an electric fieldwithin the biological subject in response to a first electric current.

At 354, the method 350 includes applying a sufficient amount of anelectrical current to the first plurality of electrodes 118 a so as togenerate a non-transcranial electric field in a region that encompassesat least one temporomandibular joint 10 of the biological subject.

In some embodiments, applying the sufficient amount of the electricalcurrent to the first plurality of electrodes 118 a comprisestransdermally delivering an electrical current to the at least onetemporomandibular joint 10 of the biological subject. In someembodiments, applying the sufficient amount of the electrical current tothe first plurality of electrodes 118 a comprises generating asubstantially prolate spheroidical electric field encompassing the atleast one temporomandibular joint 10 of the biological subject.

In some embodiments, applying the sufficient amount of the electricalcurrent to the first plurality of electrodes 118 a comprises providingan electrical current flow that occupies a region proximate to an ear ofthe biological subject. In some embodiments, applying the sufficientamount of the electrical current to the first plurality of electrodescomprises providing a sufficient amount of current to generate anon-transcranial electrical current encompassing the temporomandibularjoint 10, wherein a major portion of the non-transcranial electricalcurrent is space apart from the brain of the biological subject.

The various embodiments described above can be combined to providefurther embodiments. All of the U.S. patents, U.S. patent applicationpublications, U.S. patent applications, foreign patents, foreign patentapplications, and non-patent publications referred to in thisspecification and/or listed in the Application Data Sheet, including butnot limited to:

U.S. Pat. No. 5,273,033 issued on Dec. 28, 1993; U.S. Pat. No. 6,011,994issued Jan. 4, 2000; U.S. Pat. No. 6,321,119 issued Nov. 20, 2001; U.S.Pat. No. 6,535,767 issued Mar. 18, 2003; U.S. Pat. No. 7,117,034 issuedOct. 3, 2006; U.S. Patent Pub. No. 2004/0267333 published Dec. 30, 2004;U.S. Patent Pub. No. 2006/0293724 published Dec. 28, 2006; and U.S.Patent Pub. No. 2008/0039901 published Feb. 14, 2008; are eachincorporated herein by reference, in their entirety. Aspects of theembodiments can be modified, if necessary to employ concepts of thevarious patents, applications and publications to provide yet furtherembodiments.

These and other changes can be made to the embodiments in light of theabove-detailed description. In general, in the following claims, theterms used should not be construed to limit the claims to the specificembodiments disclosed in the specification and the claims, but should beconstrued to include all possible embodiments along with the full scopeof equivalents to which such claims are entitled. Accordingly, theclaims are not limited by the disclosure.

1.-20. (canceled)
 21. A method for treating a condition associated witha temporomandibular joint disorder, the method comprising: capacitivelydelivering a first non-transcranial electric current from a firstelectrode assembly of a first electrode and a second electrode to atleast partially flow through a first temporomandibular joint on asagittal first side of a head of a biological subject, the firstelectrode located positioned on a point proximate and externallyanterior of a first ear of the biological subject on the first sagittalfirst side of the head and the second electrode positioned on a point onthe sagittal first side of the head spaced apart from the firstelectrode.
 22. The method of claim 21 wherein capacitively deliveringthe first non-transcranial electric current includes providing asufficient current to transdermally capacitively deliver an electricalcurrent to the first temporomandibular joint of the biological subject.23. The method of claim 31 wherein capacitively delivering the firstnon-transcranial electric current and capacitively delivering the secondnon-transcranial electric current includes alternating betweencapacitively delivering the first non-transcranial electric current andcapacitively delivering the second non-transcranial electric current fora selected time period.
 24. The method of claim 21 wherein capacitivelydelivering the first non-transcranial electric current includessupplying a sufficient amount of current to capacitively generate anon-transcranial electrical current field encompassing the firsttemporomandibular joint.
 25. The method of claim 31 wherein capacitivelydelivering the first non-transcranial electric current, and capacitivelydelivering the second non-transcranial electric current includescapacitive delivery of the first non-transcranial electric current for afirst time period, followed by capacitive delivery of the secondnon-transcranial electric current for a second time period.
 26. A methodfor providing a non-transcranial electrical stimulus to a biologicalsubject using a wearable electrotherapy system adapted to be worn on ahead of the biological subject, the wearable electrotherapy systemconfigured to retain at least a first pair of electrodes externallyanterior to a first ear and disposed across a first temporomandibularjoint of the biological subject when the wearable electrotherapy systemis worn, the first pair of electrodes being sufficiently spaced apartacross the first temporomandibular joint so as to generate an electricfield within the biological subject in response to a first electriccurrent, the improvement comprising: applying a sufficient amount of anelectrical current to the first pair of electrodes so as to capacitivelygenerate a non-transcranial electric field in a region that encompassesat least the first temporomandibular joint of the biological subject.27. The method of claim 26 wherein applying the sufficient amount of theelectrical current to the first pair of electrodes comprisestransdermally capacitively delivering an electrical current to the firsttemporomandibular joint of the biological subject.
 28. The method ofclaim 26 wherein applying the sufficient amount of the electricalcurrent to the first plurality of electrodes comprises generating asubstantially prolate spheroidical electric field encompassing the firsttemporomandibular joint of the biological subject.
 29. The method ofclaim 26 wherein capacitively applying the sufficient amount of theelectrical current to the first pair of electrodes comprisescapacitively providing an electrical current flow that occupies a regionproximate to the first ear of the biological subject.
 30. The method ofclaim 26 wherein capacitively applying the sufficient amount of theelectrical current to the first pair of electrodes comprisescapacitively providing a sufficient amount of current to generate anon-transcranial electrical current encompassing the firsttemporomandibular joint, such that a major portion of thenon-transcranial electrical current is spaced away from the brain of thebiological subject.
 31. The method of claim 21, further comprising:capacitively delivering a second non-transcranial electric current froma second electrode assembly of a third electrode and a fourth electrodeto at least partially flow through a second temporomandibular joint on asagittal second side of the head of the biological subject, the thirdelectrode located positioned on a point proximate and externallyanterior of a second ear of the biological subject on the sagittalsecond side of the head and the fourth electrode positioned on a pointon the sagittal second side of the head spaced apart from the thirdelectrode.
 32. The method of claim 31 wherein capacitively deliveringthe second non-transcranial electric current includes providing asufficient current to capacitively transdermally deliver an electricalcurrent to the second temporomandibular joint of the biological subject.33. The method of claim 31 wherein capacitively delivering the secondnon-transcranial electric current includes capacitively supplying asufficient amount of current to generate a non-transcranial electricalcurrent encompassing the second temporomandibular joint.